Diethoxy(methyl)silane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 Feb - 20 Feb 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diethoxy(methyl)silane

EC Number:

217-982-3

EC Name:

Diethoxy(methyl)silane

Cas Number:

2031-62-1

Molecular formula:

C5H14O2Si

IUPAC Name:

diethoxy(methyl)silane

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Y-1205
- Physical state: clear, colourless liquid
- Stability under test conditions: stable
- Storage condition of test material: at room temperature

Test animals

Species:

rat

Strain:

other: Crl:(CD)BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc. Portage, MI, USA
- Age at study initiation: Young adult
- Weight at study initiation: 228 – 282 g
- Housing: Animals were caged in individually suspended wire-mesh cages.
- Diet: Purina Certified Rodent Chow #5002, ad libitum
- Water: (tap/filtered) water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.9 – 22.4
- Humidity (%): 44.9 – 53.2
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- % coverage: 18 - 23
- Type of wrap if used: The test material was held in contact with the skin with gauze bandaging. The bandage was secured with nonirritating tape. Collars were applied and remained on the rats for the duration of the exposure to prevent the ingestion of the test material and/or wrappings during the 24-hour exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with disposable paper towels moistened with tepid tap water.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 2.38 mL/kg bw
- Concentration: 0.84 g/mL
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 1, 3 and 4 h post administration of the test substance and twice daily thereafter for 14 days. Individual body weights were determined weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs were observed 1, 3 and 4 h post administration of the test substance and once daily thereafter for 14 days.

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occured during the study period.

Clinical signs:

other: Clinical findings were limited to wet or dried yellow urogenital staining for four rats and dried red material around the eye(s) and/or nose for three rats. These findings are typically noted in association with the bandage/collar application procedures a

Gross pathology:

Dilated renal pelves, distended ureter(s) and multiple calculi in the ureter(s) and urinary bladder were noted in one male rat at the terminal necropsy. These are common, spontaneous findings in rats of this age and strain and were unrelated to the test material. There were no other gross necropsy findings for all examined tissues.

Other findings:

Dermal observations:
Very slight erythema was noted on two male rats. Desquamation was present on six animals. There was no edema or other dermal findings. Erythema completely subsided by day 2. All dermal irritation completely subsided by day 14 or earlier.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.

Conclusions:

In conclusion, under the conditions of the present study, according to OECD 402 and GLP, the LD50 is > 2000 mg/kg bw for both male and female rats. The test substance does not need to be classified for acute dermal toxicity.